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THE GOOD
Approvals & Labels

China approves Sanofi's Tzield, first disease-modifying therapy for type 1 diabetes, based on Ph2 results
Antibody, autoimmune, monoclonal antibody, type 1 diabetes, immunomodulator, beta-cell preservation - Read more

THE GOOD
Business Development & Partnerships

PhaseV, Bioforum partner to integrate trial design software into CRO services, enhancing clinical trial optimization
Research collaboration, AI/ML, drug discovery, clinical trials, data analytics - Read more

Fangzhou, Innovent Biologics form strategic AI-powered alliance for weight management solutions in expanding $14.9B market
Strategic partnership, AI/ML, digital health, metabolic disease, weight management - Read more

Lundbeck selects Swixx BioPharma as distributor for CNS portfolio across Southeast Europe, Turkey, and Latin America
Distribution agreement, neurological, commercialization, multi-regional, CNS therapeutics - Read more

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THE GOOD
Clinical Trials

PMV's rezatapopt shows 43% response rate in Ph2 ovarian cancer trial targeting p53 pathway
Small molecule, cancer, p53 reactivator, ovarian cancer, TP53 mutation, platinum-resistant - Read more

Cullinan, Taiho's zipalertinib shows promising Ph1/2 efficacy for EGFR-mutated non-small cell lung cancer, FDA submission planned
Small molecule, cancer, tyrosine kinase inhibitor, non-small cell lung cancer, EGFR mutation, targeted therapy - Read more

Avidity's delpacibart zotadirsen (AOC) shows unprecedented functional benefits in Ph1/2 study for Duchenne muscular dystrophy patients
Oligonucleotide, rare disease, antibody oligonucleotide conjugate, Duchenne muscular dystrophy, exon skipping, dystrophin restoration - Read more

THE GOOD
Fundraises

Wellcome Leap raises $100M from Pivotal, advancing women's health research in underserved areas
Women's health, research initiative, nonprofit, cardiovascular, autoimmune disease, mental health - Read more

Odyssey Therapeutics raises $213M Series D for autoimmune disease medications pipeline
Autoimmune, small molecule, inflammatory disease, AI-driven, preclinical, clinical-stage - Read more

YolTech Therapeutics raises $44.5M Series B for mRNA delivery technology and CRISPR pipeline advancement
Gene therapy, CRISPR, mRNA-LNP delivery, clinical-stage, platform technology - Read more

Dewpoint Therapeutics raises Series D, advancing cancer condensate modulator to clinical trials
Oncology, small molecule, platform technology, gastric cancer, condensate biology, preclinical - Read more

Kriya raises $320M Series D to advance clinical-stage gene therapies for chronic diseases
Gene therapy, chronic diseases, clinical-stage, manufacturing platform, rare disease, platform-enabled - Read more

Inkocell Therapeutics raises CHF 150K ($188K) from Venture Kick, advancing NK-tailored CAR therapies
Cell therapy, NK cell therapy, oncology, platform technology, cancer, preclinical - Read more

Eyexora raises seed funding from ClavystBio, building ophthalmology device and therapeutic portfolio
Ophthalmology, platform technology, drug development, hub-and-spoke model, device development, therapeutics - Read more

THE GOOD
Investments

California awards $23.9 million to Los Angeles County life sciences projects, aiming to create 10,000 regional jobs by 2030
Biotech infrastructure, economic development, strategic, operational, investment - Read more

THE GOOD
Product Launches

IQVIA launches AI-powered clinical trial financial suite to automate payments and reduce processing times
Clinical trial software, AI technology, operational, financial - Read more

Hims & Hers Health launches testosterone therapies after financial hit from weight-loss drug restrictions
Hormone therapy, men's health, telehealth, strategic, revenue impact - Read more

THE GOOD
Regulatory

FDA issues guidance to accelerate development of non-opioid chronic pain treatments
Small molecule, chronic pain, regulatory, development pathway - Read more

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THE BAD
Lawsuits

CVS sues Takeda and TWi over alleged "pay-for-delay" scheme involving heartburn drug Dexilant
Small molecule, gastrointestinal, legal, competitive, financial - Read more

THE BAD
Layoffs

Novo Nordisk to cut 11% of workforce amid profit concerns, saving $1.26B annually
GLP-1 receptor agonist, metabolic disease, strategic, cost reduction, operational, workforce restructuring - Read more

THE BAD
Politics & Policy

ABPI report highlights UK's declining R&D investment and clinical trials, as AstraZeneca and Merck & Co. reduce commitments
Investment policy, R&D infrastructure, regulatory barriers, competitive positioning, financial impact - Read more

Trump administration considers restricting US pharma licensing of Chinese drugs amid national security concerns
Geopolitical policy, international licensing, regulatory affairs, strategic, national security - Read more

Fired CDC Director Monarez to testify before senate about conflict with RFK Jr. over vaccine policies
Public health policy, infectious disease, regulatory, operational - Read more

THE BAD
Strategic Plans

Merck & Co. abandons UK R&D operations, citing undervaluation of innovative medicines by successive governments
Strategic, financial, operational, regulatory, competitive - Read more

THE UGLY
Adverse Events

Capsida's gene therapy for STXBP1 encephalopathy halted after Ph1 patient death raises safety concerns
Gene therapy, neurological, adeno-associated virus, STXBP1 encephalopathy, pediatric, adverse event - Read more

You’re all caught up on the latest Pharma & Biotech News!

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